Prolonged Laryngeal Mask Airway ProSealTM Use

Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours

The investigators conclude that use of the LMA ProSealTM for prolonged procedures is feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided basic guidelines are followed.

Study Overview

• Status: Completed
• Conditions: Airway Management

Detailed Description

There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable for positive pressure ventilation (needed to counter the alleged progressive respiratory fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask device with a modified cuff to facilitate ventilation and a drain tube to provide airway protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM for prolonged procedures; however, there are only four reports and one case series.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Christian Keller MD, M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We describe the use of the LMA ProSealTM in seven patients in a variety of clinical situations for procedures lasting more than 5 hours.

Description

Inclusion Criteria:

• ASA 1 - 3
• Age 19-85 yr
• Written informed consent

Exclusion Criteria:

• Difficult airway
• Non fasted
• BMI > 35

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the LMA ProSealTM for prolonged use	Oropharyngeal leak pressure	30 Minutes

Collaborators and Investigators

• Sponsor: Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Schulthess_Anä_9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No